Contract research institute

from Wikipedia, the free encyclopedia

A contract research institute (also contract institute or CRO, Contract Research Organization or Clinical Research Organization ) takes on tasks in the planning and implementation of clinical studies . These are private service companies for the pharmaceutical and medical device manufacturing industry that support the research and development of drugs and medical devices.

tasks

The most important area of ​​responsibility is not the practical implementation of clinical studies carried out by investigators, but their planning, organization, support and monitoring. This includes in particular the development of the test plan in compliance with legal and often international requirements, the support of official or medical-ethical decisions, the evaluation of all side effects, the planning of the test samples, their blinding and the statistical evaluation of the results after unblinding. A CRO can also conduct clinical studies directly with its own investigator.

Economic sector

There are over 1000 different CRO companies worldwide. In 2011, the market leader Quintiles employed 23,000 people worldwide. In a study that was co-supervised by the Federal Association of the Pharmaceutical Industry (BPI), 136 contract research institutes were listed in Germany alone in 2014. 40 of the companies listed there have come together in Germany to form the "Federal Association of Contracted Medical Institutes " (BVMA), founded in 1991.

At the international level there is the ACRO (Association of Clinical Research Organizations) , which was founded in 2002 and is based in Washington, DC (USA). In October 2005 the European CRO umbrella organization - EUCROF - was founded in the Netherlands.

In 2014 the market share of the ten largest and globally operating CROs was over 50%: Quintiles 15%, Covance 9%, Parexel 8%, PRA Health Sciences 7%, Pharmaceutical Product Development LLC (PPD) 6%, ICON 4%, Charles River Labs 2%, INC Research 2%, WuXi Pharma 2% and Inventiv 2%.

See also

Contract Manufacturing Organization

literature

  • Julia Achtmann, The protection of the test person during clinical drug testing: with special consideration of the liability of those involved and the test person insurance , Springer Verlag 2012, here Chapter IV. Contract Research Organization (CRO) pages 39 and 40

Web links

Individual evidence

  1. ↑ Barbara Hoffbauer, Career Goal Life Sciences: A Career Guide , Springer-Verlag 2011, p. 45
  2. ^ Katharina Schaper, contract research institute in Germany. A systematic analysis ( Memento of May 16, 2017 in the Internet Archive ) , February 1, 2015, p. 30
  3. ↑ Jakob Miera, CRO - Contract Research Organization: How Drug Research is Evolving: How Drug Research is Evolving , Anchor Academic Publishing (aap_verlag), 2014, p. 28
  4. ↑ Paul Saias, Anuj Kapadia, CROs, convergence and commercial opportunities , KPMG-Report 2016, p. 2